Assessment of the Effects of Probiotic Supplementation on Gut Microbiota Composition and Short-chain Fatty Acid Production in Frail Elderly Patients Receiving Home Enteral Nutrition With an Oligomeric Formula.

This is an investigator-initiated, spontaneous, non-profit, randomized intervention study with two parallel arms. The study aims to evaluate the effect of a 30-days probiotic supplementation on the composition of the intestinal microbiota (MA) and the production of short-chain fatty acids (SCFAs) in faecal samples of frail elderly patients receiving home enteral nutrition (HEN) with an oligomeric formula. Participants will be monitored for gastrointestinal complications like constipation and diarrhea, and for Clostridium difficile infections.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Enteral Nutrition Frailty Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS INRCA Hospital

Ancona, 60127, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Use of oligomeric enteral formula since at least 30-days
Absence of diagnosed intestinal inflammation (e.g., Crohn's disease or ulcerative colitis).

Exclusion criteria

Antibiotic use within one month prior to enrolment
Intake of any probiotics other than the study product within one month prior to enrolment
Hypersensitivity to any probiotic ingredient
Non-exclusive enteral nutrition (minimal oral intake)

Treatment and study plan

Probiotic supplementation

Dietary Supplement

Subjects take 1 capsule/die of the probiotic SYNBIO® (Synbiotec Srl, Camerino, Italy). Each capsule contains 0.26 g of a 1:1 mixture of Lactobacillus rhamnosus IMC501® and Lactobacillus paracasei IMC502®, equivalent to a daily dose of 15 billion live probiotic cells. For enteral nutrition, the probiotic powder was suspended into 5-10 mL of water and administered directly through the feeding tube. The product is gluten-free, lactose-free, and contains no milk proteins.

Primary outcomes

Change in the gut microbiota composition

Time frame: from the enrolment to the end of study at 30 days

To evaluate the impact of 30-days probiotic supplementation on gut microbiota (GM) composition in faecal samples of frail elderly patients receiving home enteral nutrition.
Change in the production of SCFA

Time frame: from the enrolment to the end of study at 30 days

To evaluate the impact of a one-month probiotic supplementation on short-chain fatty acid (SCFA) production in faecal samples of frail elderly patients receiving home enteral nutrition.

Sponsors and collaborators

Lead sponsor

Istituto Nazionale di Ricovero e Cura per Anziani

Other

Registry information

Acronym: MICROBIOTA

Important dates

Study start: 2018
Primary completion: 2024
Study completion: 2024
First posted: Feb 27, 2026
Registry last updated: Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed